MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-05-10 for ULTRALITE PHOTO THERAPY UNIT V4408 manufactured by Ultralite Enterprises Inc.
[277572]
Customer called uei (05/08/2002) for calibration service of their unit. During the discussion of scheduling, reporter informed uei of a pt (unknown) who was burned severely in dec. Reporter had little detail on the event. Reproter did say that the pt was suing the user facility. Reporter informed the company that the unit has continued to be used since december.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045025-2002-00002 |
| MDR Report Key | 393712 |
| Report Source | 06 |
| Date Received | 2002-05-10 |
| Date of Report | 2002-05-10 |
| Date of Event | 2001-12-01 |
| Date Mfgr Received | 2002-05-08 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 2002-05-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 390 FARMER COURT |
| Manufacturer City | LAWRENCEVILLE GA 30045 |
| Manufacturer Country | US |
| Manufacturer Postal | 30045 |
| Manufacturer Phone | 7709630594 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRALITE PHOTO THERAPY UNIT |
| Generic Name | UV DERMATOLOGY LIGHT |
| Product Code | FTC |
| Date Received | 2002-05-10 |
| Model Number | V4408 |
| Catalog Number | V4408 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 382730 |
| Manufacturer | ULTRALITE ENTERPRISES INC |
| Manufacturer Address | 390 FARMER CT. LAWRENCEVILLE GA 30045 US |
| Baseline Brand Name | ULTRALITE FULL BODY PHOTOTHERAPY UNIT |
| Baseline Generic Name | ULTRAVIOLET DERMATOLOGICAL LIGHT |
| Baseline Model No | V4408 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-10 |